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Clinical Research Study Manager
Ref No.: 18-14330
Location: Thousand Oaks, California
Position Type:Scientific (T)
Start Date / End Date: 10/01/2018 to 09/30/2019
Our client, a leading biopharmaceutical company is looking for a Clinical Research Study Manager. This is for an initial duration of 12 months and is located in Thousand Oaks, CA
 
Top Skill Sets:
  • Individuals with at least 3+ years’ experience in clinical pharmacology trials (ie Bioequivalent, Drug-Drug-Interaction, Food Effect, etc…)
  • Experience in working with Phase 1 Clinical Research Unit (CRU)
  • Experience in managing outsourcing vendors (solicit RFPs/bids, developing specifications, managing vendor project managers & delivery)
  • Phase 1 experience
  • Minimum 5 years’ experience in clinical research management
  • Oncology trail experience
  • Global Trial experience
  • Strong scientific background- academic or experience in clinical research setting.
  • Protocol writing experience- a plus
  • Strong authoring protocols experience in clinical study reports.
 
Responsibilities:
  • Planning, management and reporting of clinical studies conducted by Early Development or the Functional Service Provider through oversight of cross-functional study activities
  • Identification and resolution of issues
  • Communication of study timelines and deliverables ensuring studies are conducted in accordance with SOPs, GCP and regulatory guidance
  • Contributing to the First in Human Portal document/Global Development Plan
  • Contributing to/authoring protocols, relevant sections of annual safety reports, clinical study reports, and publications
  • Management and/or oversight of study budget, timelines and insourcing/outsourcing partners to the required standards
 
Preferred Qualifications:
  • MS or RN
  • 7+ years of experience in life sciences or medically related field
  • 4+ years of bio-pharmaceutical clinical research experience obtained working on industry-sponsored or industry-partnered clinical trials at academic institutions or working on clinical trials in a biotech, pharmaceutical or CRO company
  • Management experience of direct reports
  • Experience in oversight of Functional Service Providers, outside vendors (CRO’s, central labs, imaging vendors, etc…)
 
Basic Qualifications:
  • Doctorate Degree OR
  • Master's Degree and 3 years of Clinical experience OR
  • Bachelor's Degree and 5 years of Clinical experience OR
  • Associate's degree and 10 years of Clinical experience OR
  • High school diploma/GED and 12 years of Clinical experience
 
Qualified candidates please send your word format updated resume at the earliest to sangeeth.k@sunrisesys.com.  Thank You.